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Completed

NCT Number: NCT01693341

A Caregiver-mediated Intervention Improves the Functional Ability of Home-living Chronic Stroke Patients

To examine the feasibility of improving stroke patients' physical functional recovery and social participation through improving caregiver's care capability.

Completed

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph Hospital

Kaohsiung City, 80288, Taiwan

About this study

In the hospital, most rehabilitation units are like sheltered workshops and the therapists work with stroke patients in well-designed, but non-home-like, environment to improve the stroke patient's functional ability. After returning home, stroke patients face new challenges and also need to assume more responsibility for daily activities. Without continuing rehabilitation training or proper support, the patients can easily fall into a sedentary lifestyle and lead to declines in functional ability.However, providing home-based exercise by therapists directly would increase the health care cost and may not be practical for chronic stroke patients. Hence, the objective of the present study was to determine whether a caregiver-mediated, home-based intervention program is effective for improving stroke patients' functional ability and social participation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >6 months post first stroke with mild to moderate disability (Brunnstrom stage III-V)
  • No longer undertaking active rehabilitation program(defined as ≤2 times/wk rehabilitation activities)

Exclusion criteria

  • Recurring strokes
  • Mental or cognitive impairment
  • Severe orthopedic disability or unstable medical conditions (such as severe rheumatoid arthritis or acute myocardial infarction)
  • Caregiver with mental/behavioral disorders

Treatment and study plan

Care-giver mediated training

Other

A physical therapist visited each subject and the caregiver (of the intervention group) once weekly for about 90 min/session to teach patient-skills and caregiver-skills. The therapist first reviewed the condition of each patient and planned patient-specific training programs, continuously performed 12 weeks.

Primary outcomes

  1. Stroke Impact Scale

    Time frame: Baseline and 12 weeks

    Change from baseline in Stroke Impact Scale at 12 weeks

Secondary outcomes

  1. 10-meter walking speed

    Time frame: Baseline and 12 weeks

    Change from baseline in 10-meter walking speed (cm/sec) at 12 weeks

  2. Berg balance scale

    Time frame: Baseline and 12 weeks

    Change from baseline in berg balance scale score at 12 weeks

  3. 6-min walking distance

    Time frame: Baseline and 12 weeks

    Change from baseline in 6-min walking distance at 12 weeks

  4. Bathel index score

    Time frame: Baseline and 12 weeks

    Change from baseline in Bathel index score at 12 weeks

  5. Lawton Instrumental Activities of Daily Living scale (IADL)

    Time frame: Baseline and 12 weeks

    Change from baseline in Lawton Instrumental Activities of Daily Living Scale at 12 weeks

  6. Fugl-Meyer Assessment Scale

    Time frame: Baseline and 12 weeks

    Change frome baseline in Fugl-Meyer Assessment Scale score at 12 weeks

Other outcomes

  1. Center for Epidemiologic Studies Depression Scale

    Time frame: Baseline and 12 weeks

    Change from baseline in Center for Epidemiologic Studies Depression Scale score at 12 weeks

  2. Caregiver Burden Scale

    Time frame: baseline and 12 weeks

    Change from baseline in Caregiver Burden Scale at 12 weeks

Sponsors and collaborators

Lead sponsor

Asia University

Other

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Official study title

Caregiver-mediated Intervention in Home-living Chronic Stroke Patients

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 26, 2012
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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